FDA Registration Active 🇺🇸 United States

Camera Starter Kit

Reg #: 3015612252 · FEI: 3015612252 · Expires 2025
Products
1
Proprietary Names
22
Establishment Types
1
Classifications
1

Registration Details

Registration Name
INTUITIVE SURGICAL, INC.
Registration Number
3015612252
FEI Number
3015612252
Status
Active
Expiry Year
2025
Initial Importer
Yes
Address
3410 Central Expressway, --
City
Santa Clara
State
CA
ZIP
95051
Country
US

Regulatory Submissions

510(k) Number
K081137

Owner / Operator

Firm Name
Intuitive Surgical, Inc.
Operator Number
9028901
Address
1266 Kifer Road, --
City
Sunnyvale
State
CA
Postal Code
94086
Country
US
Correspondent
Mario Lowe

Products

Device Name Product Code
System, Surgical, Computer Controlled Instrument NAY

Proprietary Names

Camera Starter Kit 12 mm Endoscope, 0° ASSY,PSCART,IS3000,4-ARM ASSY,PSCART,IS3000,3-ARM ASSY,SSC,IS3000 3DHD Camera Head and Cable CABLE KIT,BLUE FIBERCONNECT,20M Accessory Base Starter Kit KIT,CABLE,FIBER OPTIC,ST,CIRCULAR-MT M-F Energy Activation Cable, ERBE, da Vinci Si Energy Activation Cable, CONMED, da Vinci Si VisionBoom¿ Extension Cable Energy Activation Cable, Valleylab, da Vinci Si Option, Connect, da Vinci Si VIO-ICB Mounting Bracket da Vinci Surgical System, Si Cannula Seal, 8mm 12 mm Endoscope, 30° Energy Activation Adapter, Ethicon GEN11, da Vinci Si Energy Activation Cable, Ethicon, da Vinci Si Energy Activation Cable, Gyrus, da Vinci Si ASSY,VSS VISION SYSTEM W/AVP,VS3000

Establishment Types

Complaint File Establishment per 21 CFR 820.198